Latest / Medical Device Global Market Access
Colombia's INVIMA Approval Timelines: Standard vs. Expedited Medical Device Pathways
This episode explores the medical device registration process in Colombia, focusing on the timelines set by the regulatory authority, INVIMA. We break down the key differences between the standard (controlled) review pathway for high-risk devices and the expedited (automatic) process for lower-risk devices, including eligibility requirements and realistic time-to-market estimates for each. This is essential information for any MedTech company considering market entry into Colombia. - What is INVIMA and what is its role in regulating medical devices in Colombia? - How long does the standard…
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